CAJ | 학술논문

目的：探讨同一实验室不同检测系统的可比性。方法：按照美国临床实验室标准化协会(NCCLS)EP9-A2文件要求，以贝克曼-库尔特DXC-800系统为目标系统，日立7600检测系统为比较检测系统，每天随机选取8份体检者新鲜血液标本，测定ALT,AST,Cr,GLU4个常规生化指标，连续测5d，记录测定值，计算贝克曼-库尔特DXC-800系统（X）和日立7600系统（Y）的相关系数r和相对偏移（SE%），以国家卫计委推荐的TEa的1/2为标准，分析两个系统的相关性以及评价两个系统的临床可接受性。结果：两个系统相关性良好，r2>0.95，两个系统检测的4各项目在低、中、高三个医学决定水平的SE%均小于1/2国家卫计委推荐的总误差（TEa），比较无差异性，为临床可接受。结论：定期用新鲜血进行比对试验，对同一实验室的两个生化检测系统进行相关性和可接受性评价十分必要，满足了ISO/IEC17025和ISO15189对实验室提出的要求，既保证了检验质量也为实验室认可提供了依据。
목적：탐토동일실험실불동검측계통적가비성。방법：안조미국림상실험실표준화협회(NCCLS)EP9-A2문건요구，이패극만-고이특DXC-800계통위목표계통，일립7600검측계통위비교검측계통，매천수궤선취8빈체검자신선혈액표본，측정ALT,AST,Cr,GLU4개상규생화지표，련속측5d，기록측정치，계산패극만-고이특DXC-800계통（X）화일립7600계통（Y）적상관계수r화상대편이（SE%），이국가위계위추천적TEa적1/2위표준，분석량개계통적상관성이급평개량개계통적림상가접수성。결과：량개계통상관성량호，r2>0.95，량개계통검측적4각항목재저、중、고삼개의학결정수평적SE%균소우1/2국가위계위추천적총오차（TEa），비교무차이성，위림상가접수。결론：정기용신선혈진행비대시험，대동일실험실적량개생화검측계통진행상관성화가접수성평개십분필요，만족료ISO/IEC17025화ISO15189대실험실제출적요구，기보증료검험질량야위실험실인가제공료의거。
Objective:To discuss the comparability of different detection systems in the same laboratory.Methods:According to NCCLS document EP9-A2,ALT,AST,Cr and GLU of 8 random fresh blood samples were detected by Beckman Coulter testing system(targeted testing system)and Hitachi7600 biochemical analyzer system(comparative testing system) continuously for 5 days.After we recorded the data,we calculated the correlation coefficients(r) and the relative deviation(SE%) of Beckman Coulter testing system(X) and Hitachi7600 biochemical analyzer sysyem(Y).According to the half of TEa recommend by national health development planning commission,we evaluate the correlation and the clinical acceptability of the two systems.Results:The correlation of the two systems is good.Correlation coefficients(r2) ≥0.95.The relative deviations(SE%) in the 3 medical decision level of the 4 projects are less than the half of TEa recommend.The two detection systems had no significant difference.The results detected by the two detection systems are acceptable.Conclusions:To do the comparison using fresh blood samples and to Using fresh blood samples to do the comparison test to evaluate the correlation and clinical acceptability of two different detection systems in the same laboratory is very necessary on a regular basis. The comparison test meet the requirement of ISO/IEC 17025 and ISO 15189 and ensure the quality of laboratory experiment. It also provides the basis for laboratory accreditation.